An Aggregation of Recent eCTD News
Some people who read this blog may be aware that I also post eCTD-related updates on my twitter account (www.twitter.com/kathie_clark). I use this medium to post agency news updates, information I hear from the regulators, and interesting articles or presentations that I come across. For more significant news, I usually follow up with a blog posting.
Recently, several people who read the blog have told me that, due to company restrictions, they are not able to follow twitter updates. In addition, there are certainly people who just don’t like twitter (and I can sympathize as there is certainly a lot more trivia and minutia than useful content on most twitter postings). These colleagues have suggested that I periodically summarize the more interesting information I post on twitter on a blog posting as well. Today, I’m taking them up on that suggestion. For part 1, here is a variety of news I posted on Twitter since February 1, 2010, related to interesting white papers, webinars, presentations, blog postings, and online articles. Next post will feature agency news, documents and presentations.
Interesting White Papers, Webinars and Presentations
- GlobalSubmit has several free white papers available to sponsors – request by emailing email@example.com:
- Ensuring eCTD Quality: Points to Consider for Regulatory Affairs Professionals
- 5 Key Recommendations for Improving eCTD Module 3 Quality & Reviewability
- What Makes an eCTD Clinical Study Easily Reviewed by the FDA?
- GlobalSubmit is also presenting an encore of our free webinar Get up to date on the Regulated Product Submission standard on April 1st at 1 PM EST.
- Download the podcast “How to Prepare Your Product Dossier for Global Simultaneous eCTD/CTD Submissions – A Look at Tools, Tips and Taking the Mystery Out of Submission Planning and Publishing” by Meredith Sewell, Associate Director, Global Regulatory Affairs Publishing, Allergan, Inc. Meredith is an excellent speaker and an eCTD veteran with many practical suggestions.
Online Articles and Blog Postings
- To learn more about how the different agencies group eCTD sequences into regulatory activities for review, read Secrets of eCTD Related Sequences at Applied Clinical Trials Online.
- Antoinette Azevedo, President & CEO, e-SubmissionSolutions.com, contributed Speeding Time To Market For Pharmaceutical & Biotechnology Companies on GxP Lifeline. This article looks at taking advantage of the eCTD format – and consequences of not doing so.
- A blog posting on Monte Leveson’s “Aerie Canal” blog provides sound advice on Final Submission QC, and even includes a sample QC sheet in MS Word format that you can modify for your own use: Final QC Sheet. The ForeignExchange Translations blog further commented on Final QC of electronic submissions.
- Dr Martin Moxham of iRegulatory commented on the potential of PIM to make the lives of regulatory professionals easier, and concluded “a switch to managing product information in structured format (such as PIM) has clear benefits in terms of decreased resource requirements, decreased cost, enhanced quality and ease of management of translation.”
- GxP Lifeline featured an article by Cato’s Rachel Cooper – Strategies for eCTD Marketing Application Submissions. This article talks about project management tools such as the integrated Table of Contents (spreadsheet) and rolling submission management.
- The Medical Translation Insight blog posted Bulgaria catches up with e-submissions, which talks about the progress that this agency has made in completing readiness preparations in the last several yearz.
- The eCTD Upgrade: Cross-Application Linking on the PharmTech web site provides some tips on cutting time and cost by re-using already submitted documents. As a quick reminder, this applies to US submissions only as cross application linking is not accepted by EMEA.
- The BayBio blog posted a good basic overview: eCTD Submission Specifications.
- The Dante Resource Group Blog contributed Preparing a CTD, eCTD Project Planner for your clinical submission.
- GlobalSign provided a useful list of Frequently asked questions when using a GlobalSign Digital ID to submit documents to the FDA eSubs Gateway ESG.
So, to wrap up: if you have made it this far and found “news you can use” in this article, you may want to consider following me on Twitter so you get a more timely update. If you have a twitter account, this is easy to do, but even if you don’t, you can just go to the web page www.twitter.com/kathie_clark for the latest updates (and the last three tweets always appear on the upper left column of this blog). You may also want to follow my company, GlobalSubmit, at www.twitter.com/globalsubmit. You don’t actually need a twitter account to do this.